Notice of Clarification of Applications Accepted in Response to PAR-16-034, Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01)

Notice Number: NOT-DK-17-009

Key Dates
Release Date:   March 7, 2017

Related Announcements
PAR-16-034  

Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK

Purpose

The purpose of this Notice is to clarify PAR-16-034 "Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01)" by removing this text from Section I: "This FOA may not be used to extend the duration of the parent study. An award for an ancillary study will be contingent on a programmatic determination as to whether the study can be completed within the funding period of the parent study." The PAR allows ancillary studies with components that cannot be completed within the funding period of the parent study if a detailed plan, including associated costs, is provided describing the components of the ancillary study that will be performed after the parent study ends and how these activities will be accomplished.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Currently reads:

Studies submitted under this FOA must collect new information and/or biological samples from participants enrolled in the ongoing parent study. Ancillary studies which use data and/or biological samples previously collected may be submitted to the NIH parent R01 FOA (PA-13-302), the NIDDK Repository FOA (PAR-13-228) or other relevant NIH FOAs. Investigators conducting primarily data analyses may wish to consider PA-15-169 (Secondary Analyses in Obesity, Diabetes and Digestive and Kidney Diseases (R21)). The proposed ancillary study should primarily focus on participants in the parent study, although recruitment of a comparator population for a specific measurement or a population that will substantially enhance the findings of the parent study is appropriate.  Collection of data or biological samples for ancillary studies proposed under this FOA must be completed within the funding period of the parent study or a detailed plan, including associated costs, must be provided describing what components of the ancillary study will be performed after the parent study ends and how those activities will be accomplished. This FOA may not be used to extend the duration of the parent study. An award for an ancillary study will be contingent on a programmatic determination as to whether the study can be completed within the funding period of the parent study.

Modified to read:

Studies submitted under this FOA must collect new information and/or biological samples from participants enrolled in the ongoing parent study. Ancillary studies which use data and/or biological samples previously collected may be submitted to the NIH parent R01 FOA (PA-13-302), the NIDDK Repository FOA (PAR-13-228) or other relevant NIH FOAs. Investigators conducting primarily data analyses may wish to consider PA-15-169 (Secondary Analyses in Obesity, Diabetes and Digestive and Kidney Diseases (R21)). The proposed ancillary study should primarily focus on participants in the parent study, although recruitment of a comparator population for a specific measurement or a population that will substantially enhance the findings of the parent study is appropriate.  Collection of data and/or biological samples for ancillary studies proposed under this FOA must be completed within the funding period of the parent study or a detailed plan, including associated costs, must be provided describing what components of the ancillary study will be performed after the parent study ends and how those activities will be accomplished.

All other aspects of this Funding Opportunity Announcement remain the same.

Inquiries

Please direct all inquiries to:

Mary Evans, Ph.D. 
Division of Digestive Diseases and Nutrition 
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4578 
Email: evansmary@niddk.nih.gov

Saul Malozowski, M.D., Ph.D., M.B.A.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-4683
Email: sm007@nih.gov

John W. Kusek, Ph.D.
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7735
Email: jk61x@nih.gov